Exceptional regulatory situations have been allowed recently due to the coronavirus pandemic.
Exceptional regulatory situations have been allowed recently due to the high demand for specific health resources, and the need to design new products that can impede the advancement of the coronavirus pandemic. These scenarios include emergency regulatory approvals and lowered regulatory requirements to manufacture and distribute devices in response to COVID-19.
One of the most necessitated devices during this pandemic are ventilators that provide life-saving treatments for patients with COVID-19. Significant regulatory concessions have been made in the United States and in Europe to increase the production and marketing of this specific type of device.
On February 4, 2020, the Department of Health and Human Services (HHS) declared a public health emergency in the United States. The HHS reported the justified need for emergency use of in vitro diagnostics, personal respiratory protective devices, and medical devices. In response, the Food and Drug Administration (FDA) implemented exemptions by authorizing the use of devices through Emergency Use Authorizations (EUAs). FDA granted EUA for products that diagnose, treat, or prevent COVID-19.
The EUA program allows the marketing of unapproved medical devices or new uses of approved products. The EUA requires fulfillment of some specific conditions, e.g., monitoring and reporting of adverse events, limited distribution, administration, and advertising, and the termination of authorization when HHS determines that the justified declaration has ended. The EUA may also expire if the product receives approval or clearance.
The FDA has also allowed exceptions to the application of the law for specific devices. Specific patient monitoring devices, ventilators, and other respiratory devices are now exempt from submitting a premarket notification (510(k)) when the modification does not create undue risk. Face masks not intended for a medical purpose do not need FDA device marketing authorization and the requirements of the FD&C do not apply. For face masks intended for a medical purpose and surgical masks do not require 510(k). Sterilizers, disinfectant devices, and air purifiers designed to eliminate the virus are not challenged by the FDA, even when no premarket notification (510(k)) has been submitted.
The European Union also implemented extraordinary regulatory measures in response to the global emergency. One of the most notable announcements is the delay in the implementation of the European Union Medical Devices Regulation (EU MDR 2017/745). The European Commission’s decision to delay the application of MDR until May 26, 2021, was partly due to the impact of COVID-19, and also the lack of capacity to carry out conformity assessments by European Notified Bodies.
Unlike the United States, with its centralized regulatory Agency, the European Union relies on competent authorities in each member state (country). Most European national competent authorities (NCA) have implemented emergency scenarios, which allows for the approval of non-compliant devices. These exemptions are the responsibility of each country. As an example, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom issued a specification for a “Rapidly manufactured Ventilator System” (RMVS). The MHRA also published a guide to the clinical requirements for a “minimally acceptable” ventilator for hospital use during the COVID-19 outbreak. The aim is to meet the high demand for ventilators in the UK. In summary, the RMVS specification states that the Agency accepts that RMVS are not CE marked and therefore did not comply with all applicable standards. Still, these devices are subject to the “Exceptional use of non-CE marked medical devices” program.
In Spain, the Spanish Agency for Medicines and Healthcare Products (SAMHP) also proposed a solution to achieve higher availability of ventilators in hospitals. The SAMHP has published a text indicating the minimum requirements and tests needed for ventilator prototypes. The guideline specifies that these prototypes can be used exclusively in clinical research.
This global health crisis has forced regulatory agencies in all countries to find ways to enable that life-saving medical technology available, while at the same adapting to the severe and multiple challenges that the COVID-19 pandemic is presenting.